On May 12, 2021, we announced that The U.S. Food and Drug Administration (FDA) Office of Neuroscience granted our appeal of the clinical hold on our Phase 1 study after almost two years of clinical hold. Initially placed on clinical hold by the FDA in 2019, the MT2 study protocol is a Phase 1, open-label, multi-site research study to assess the safety and psychological effects of MDMA-assisted therapy in healthy volunteer therapists undergoing training to treat patients suffering from posttraumatic stress disorder (PTSD) with MDMA-assisted therapy, developed by MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS. Personal experience is widely considered to be an important element in preparation and training to deliver psychedelic-assisted therapies.
The hold, lifted on May 11, 2021, was placed by the FDA due to concerns about the scientific merit of the study, risk-to-benefit ratio for healthy therapist participants, and the credentials of clinical investigators. If MAPS’ appeal was not granted, the hold would have required that the Lead Facilitator in each two-person facilitator team hold an M.D., Ph.D., or equivalent degree and that the physician be on-site instead of on-call during the treatment sessions. Read the full press release here.